New Obesity Fighter Approved By FDA

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DALLAS — Theresa Stewart spends a dozen hours a day at a computer. A sedentary job, she knows, has contributed to health problems. “I believe that if I lost the weight,” she said, “I would not be a type-2 diabetic.” Patients like her, with an obesity-caused medical complication such as diabetes, might be good candidates for a new FDA-approved device.

The Maestro Rechargeable System from EnteroMedics is the first FDA-approved anti-obesity device since 2007. It’s a surgically implanted hunger sensor. Wires placed at the top of the stomach send thousands of pulses to the abdominal vagus nerve, blocking signals between the stomach and the brain.

The vagus nerve is involved in regulating stomach emptying and signalling to the brain that the stomach feels empty or full. Though the specific mechanisms for weight loss due to use of the device are unknown, according to the FDA, it’s believed the Maestro’s pulses trick the body into feeling full.

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Dr. Priscillla Hollander, who has researched and conducted many clinical trials on diet drugs, questions whether the Maestro’s modest potential for weight loss is worth the risk of surgery. “Some of the patients lost 20% of their excess weight,” Hollander said. “If their excess weight — above their ideal weight — is 50 pounds, then they maybe only lost 10 pounds.” Hollander points out that’s only a bit more than what many diet pills promise, and all surgery comes with risk.

The Maestro and the surgery to implant it are estimated to cost around $20,000 — slightly more than lap-band surgery, but less expensive than gastric bypass. External controllers allow the patient to charge the device.

Health care professionals can adjust the setting to optimize therapy. The device can be removed. The Maestro might control hunger pangs, but it doesn’t address the psychology of food addiction.

Theresa Stewart said overeating isn’t her problem, so this device isn’t for her. “It would have to take away my love of Coke,” she said of her weakness for soda. “I don’t think it would do that.” She knows cutting high-calorie soda and getting up from the desk is cheaper and safer than surgery. But, she admits, those actions can be hard to do.